Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study

NCT07285928 | Not Yet Recruiting

• 1 other identifier: DR250159 - HYDROPULSE
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single-center, prospective, analytical cohort study. All included patients will undergo transcranial ultrasound (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization in the neurosurgery department, followed by a second ultrasound assessment either at one year after surgery for operated patients, or at one year after the initial ultrasound assessment for non-operated patients. This ultrasound evaluation will be integrated into the routine work-up, which is already systematically performed in cases of suspected idiopathic normal pressure hydrocephalus (iNPH). The neurosurgical team's decision to perform cerebrospinal fluid (CSF) shunting will be made blinded to the ultrasound measurements and based solely on the standard clinical protocol. The primary objective of the study is to demonstrate that the mean amplitude of cerebral pulsatility (MeanBTP) prior to subtractive lumbar puncture is significantly higher in patients who show clinical improvement 12 months after CSF shunting compared with those who do not, with a type I error risk (alpha) of 0.05."

Conditions

Brain Pulsatility; Idiopathic Normal Pressure Hydrocephalus (INPH)

Keywords

transcranial ultrasound; cerebral pulsatility; idiopathic normal pressure hydrocephalus (iNPH),

Outcome Measures

Primary Outcomes (1)

• Clinical improvement

  Clinical improvement at 12 months in patients who undergo CSF shunt surgery (ventriculoperitoneal shunt, VPS). Clinical improvement will be defined as cognitive improvement at 12 months and/or gait improvement at 12 months. * Cognitive improvement: improvement in at least two cognitive tests. Improvement in a single test will be defined as an increase ≥ 1 standard deviation between the baseline pre-lumbar puncture (pre-LP) speech therapy evaluation and the 12-month postoperative assessment. * Gait improvement: improvement in the Get Up and Go test and/or the 10-meter walk test (10MWT) between baseline and the 12-month postoperative assessment.

  12 months

Secondary Outcomes (7)

• Mattis Dementia Rating Scale score (MDRS)

  12 months

• Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)

  12 months

• Get Up and Go test (s)

  12 months

• 10-meter walk test

  12 months

• Reduction in modified Rankin Scale score (≤ 1 point compared with baseline) at 12 months

  12 months

Study Arms (2)

patients improved after CSF shunting surgery

patients not improved after CSF shunting surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult with suspected iNPH, hospitalized at Tours University Hospital for "hydrocephalus assessment"

You may qualify if:

• Adult
• Suspected iNPH (= at least 1/3 of the triad symptoms + ventriculomegaly on brain imaging)
• Hospitalised at Tours University Hospital for 'hydrocephalus assessment'
• Patient who has provided written and signed consent
• Individuals who objected to data processing
• Walking assessment by the physiotherapy team impossible AND cognitive assessment by the speech therapy team impossible

You may not qualify if:

• Patients already fitted with a CSF shunting system (VPS)
• Suspicion of obstructive hydrocephalus (aqueduct stenosis, tumour, etc.)
• Patients under legal protection (guardianship, curatorship, judicial protection).

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

university hospital, Tours

Tours, 37044, France

Location

Related Publications (28)

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Study Officials

• Ilyess ZEMMOURA, Pr

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilyess ZEMMOURA, Pr

CONTACT

218370813; ilyess.zemmoura@univ-tours.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 16, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (1)